Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study

Phase 4

Active, not recruiting

• Conditions: HPV
• Interventions: Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine

• Registration Number: NCT06588257
• Lead Sponsor: Fundación Huésped

Brief Summary

Protocol Title: "Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex with Men (MSM): A Pilot Study.

Detailed Description

Protocol Number: FH-79

Study Objetives:

* Evaluate the acceptability, uptake, and completion of HPV vaccination.

* Determine the baseline prevalence (before HPV vaccination) and incidence of vaccine-specific genotypes of nonavalent HPV in the anus (anatomical site) after vaccination.

* Determine the initial prevalence (before HPV vaccination) and incidence of anal cytological lesions after HPV vaccination.-

* Determine the initial prevalence (before HPV vaccination) and incidence of oral and anogenital lesions associated with HPV, according to physical examination, after HPV vaccination.

* Analyze barriers and facilitators to the acceptability, uptake, and completion of HPV vaccination from the perspective of MSM and TGW.

Patient Population: MSM (men who have sex with men) and TGW (transgender woman)

Study design: Phase IV. Longitudinal and prospective study for which a cohort of 100 MSM (men who have sex with men)and TGW (transgender woman) will be formed at Fundación Huésped. Pilot study of mixed quantitative and qualitative methodology.

Regimens: Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD), Duration: 12 months

Sample size: 105 subjects

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-10-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-04-09
• Study Completion: 2026-04-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 101

Inclusion Criteria

• Accept participation in the study by signing informed consent

• Age ≥18 years old

• People who consider themselves men who have sex with men or transgender women

• All eligible people with HIV must meet the following:

  1. stable antiretroviral treatment during the last 6 months and with undetectable viral load (depending on the method used for measurement) within the same period (the participant can bring a laboratory report carried out in the last 6 months). Regarding ART, a change associated with toxicity or simplification may be allowed before 12 weeks of the selection visit, with undetectable VL between 12 weeks and the selection visit; and
  2. CD4 cell count ≥ 200 cells/ml in the last 6 months (participant can bring a laboratory report from the last 6 months)

Exclusion Criteria

• Have a history or current suspicion of cancer
• Have a known history or current suspicion of high-grade lesion or anal intraepithelial neoplasia related to HPV.
• Have received any dose of HPV vaccine at some time in your life.
• Have received any vaccine in the last 30 days.
• Have a known allergy to any of the components of the HPV vaccine.
• Have a history of a previous severe allergic reaction, regardless of the cause.
• Presenting an acute illness that could alter the study evaluations or could put the participant at risk, according to the researcher's criteria.
• Present chronic or acute immunosuppression (except HIV).
• Have received antineoplastic and immunomodulatory agents or radiotherapy in the 6 months prior to the study or plan to receive these treatments during the study period.
• Having chronic diseases without adequate control.
• Have a diagnosis of ongoing malignant disease.
• Having received immunoglobulins, blood or blood products in the last 3 months.
• Do not participate in another intervention study
• That he is not an employee or first-degree relative of any member of the institution.
• Any condition or clinical situation where it is considered that participation in the study may pose a risk to the patient.* * People with chronic HBV infection, who are receiving treatment and have normal transaminases for the last 6 months can be included in the study. People with chronic HCV infection can enter the study if they have normal transaminases for the last 6 months and do not plan to start treatment during the study. In either case, transaminases can be requested through the study if they are not available.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Men who have sex with men with HIV	Non-infectious adjuvanted recombinant nonavalent HPV vaccine	Evaluate the acceptability, uptake, and completion of HPV vaccination.
Transgender women with HIV	Non-infectious adjuvanted recombinant nonavalent HPV vaccine	Evaluate the acceptability, uptake, and completion of HPV vaccination.
Men who have sex with men without HIV	Non-infectious adjuvanted recombinant nonavalent HPV vaccine	Evaluate the acceptability, uptake, and completion of HPV vaccination.
Transgender women without HIV	Non-infectious adjuvanted recombinant nonavalent HPV vaccine	Evaluate the acceptability, uptake, and completion of HPV vaccination.

Primary Outcome Measures

Name	Time	Method
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.	12 months	To evaluate uptake HPV vaccination, the proportion of who receiving the first dose of HPV vaccine among those who have entered the study will be estimated, and to assess HPV vaccination completion, the proportion of who receiving three doses of HPV vaccine among those enrolled will be estimated.

Secondary Outcome Measures

Name	Time	Method
Frequency of anal HPV genotypes	12 months	To determine the prevalence and incidence of anal HPV genotypes (considering the genotypes in the nonavalent vaccine), HPV genotype from anal samples will be performed to determine the frequency of anal HPV at baseline (day 1), month 6 and month 12.
Frequency of anal HPV related cytologic lesions	12 months	To determine the prevalence and incidence of anal HPV-associated cytological lesions, anal cytology will be performed to determine the frequency of anal HPV associated cytological lesions at baseline (day 1), month 6 and month 12.

Trial Locations

Locations (1)

Fundación Huésped; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina